BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH

    MDR report key: 25272399 · Received May 25, 2026

    Report

    Report Number
    1911916-2026-00238
    Event Type
    Malfunction
    Date Received
    May 25, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 6.4. ADDITIONAL 510K: K003553;

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL, LIP ON THE FLANGE OF THE SYRINGE CAUSING THE MEDFUSION PUMPS TO ALERT WITH A MESSAGE OF "OCCLUSION". ADDITIONAL INFORMATION: PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 05-07-2026 PLEASE PROVIDE THE BATCH# OR LOT# NUMBER? LOT #5336234 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. OUR TEAM IS INDICATING THERE IS A LIP ON THE FLANGE OF THE SYRINGE CAUSING THE MEDFUSION PUMPS TO ALERT WITH A MESSAGE OF "OCCLUSION." HAS SOMETHING CHANGED WITH THESE? THE REGULAR SYRINGES DON'T HAVE THIS LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548909 POSIFLUSH SET, ADMINISTRATION, INTRAVASCULAR NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5336234 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1